AVTOZMA

Product NDC: 72606-042
11-digit product format: 726060042
Labeler code: 72606
Product ID: 72606-042_f9541543-b983-4663-9c9f-c3210efd5f8a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tocilizumab
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: CELLTRION USA, Inc.
Application: BLA761420
Marketing category: BLA
Marketing start: 2025-01-26
Substance: TOCILIZUMAB
Active strength: 80 mg/4mL
Pharmacologic classes: Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: AVTOZMA
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOCILIZUMAB	80 mg/4mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
I031V2H011	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2705425	Internal RxNorm lookup
2705432	Internal RxNorm lookup
2705435	Internal RxNorm lookup
2705439	Internal RxNorm lookup
2705443	Internal RxNorm lookup
2705448	Internal RxNorm lookup
2705450	Internal RxNorm lookup
2705451	Internal RxNorm lookup
2705452	Internal RxNorm lookup
2705453	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
581c288f-8015-40ef-a4c3-683c96db193d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9f5f0f3b-b458-45da-a406-00e2782d440a	Product name	1	20150818

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72606-042-01	AVTOZMA	1 in 1 CARTON	INJECTION, SOLUTION	1	4
72606-042-01	AVTOZMA	4 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	4	4
72606-042-02	AVTOZMA	4 in 1 CARTON	INJECTION, SOLUTION	4	4
72606-042-02	AVTOZMA	4 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	4	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72606-042-01	ML - Milliliter	72606-042	02d3322b-d9cc-4b5d-abeb-060ad4a615e3	1	2025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72606-042	AVTOZMA (TOCILIZUMAB) INJECTION, SOLUTION [CELLTRION USA, INC.]	2	Current NDC, 4 package rows	20250221_581c288f-8015-40ef-a4c3-683c96db193d.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AVTOZMA	TOCILIZUMAB	CELLTRION USA, Inc.	581c288f-8015-40ef-a4c3-683c96db193d	2026-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA761420 ndc (product): 72606-042

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761420	Avtozma	tocilizumab-anoh	351(k) Interchangeable	Rx	2026-07-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
I031V2H011	TOCILIZUMAB	375823-41-9	TOCILIZUMAB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2705439	Avtozma 162 MG in 0.9 ML Auto-Injector	PSN	581c288f-8015-40ef-a4c3-683c96db193d	4
2705432	Avtozma 162 MG in 0.9 ML Prefilled Syringe	PSN	581c288f-8015-40ef-a4c3-683c96db193d	4
2705448	Avtozma 200 MG in 10 ML Injection	PSN	581c288f-8015-40ef-a4c3-683c96db193d	4
2705451	Avtozma 400 MG in 20 ML Injection	PSN	581c288f-8015-40ef-a4c3-683c96db193d	4
2705453	Avtozma 80 MG in 4 ML Injection	PSN	581c288f-8015-40ef-a4c3-683c96db193d	4
2705435	tocilizumab-anoh 162 MG in 0.9 ML Auto-Injector	PSN	581c288f-8015-40ef-a4c3-683c96db193d	4
2705425	tocilizumab-anoh 162 MG in 0.9 ML Prefilled Syringe	PSN	581c288f-8015-40ef-a4c3-683c96db193d	4
2705443	tocilizumab-anoh 200 MG in 10 ML Injection	PSN	581c288f-8015-40ef-a4c3-683c96db193d	4
2705450	tocilizumab-anoh 400 MG in 20 ML Injection	PSN	581c288f-8015-40ef-a4c3-683c96db193d	4
2705452	tocilizumab-anoh 80 MG in 4 ML Injection	PSN	581c288f-8015-40ef-a4c3-683c96db193d	4
2705439	0.9 ML tocilizumab-anoh 180 MG/ML Auto-Injector [Avtozma]	SBD	581c288f-8015-40ef-a4c3-683c96db193d	4
2705432	0.9 ML tocilizumab-anoh 180 MG/ML Prefilled Syringe [Avtozma]	SBD	581c288f-8015-40ef-a4c3-683c96db193d	4
2705448	10 ML tocilizumab-anoh 20 MG/ML Injection [Avtozma]	SBD	581c288f-8015-40ef-a4c3-683c96db193d	4
2705451	20 ML tocilizumab-anoh 20 MG/ML Injection [Avtozma]	SBD	581c288f-8015-40ef-a4c3-683c96db193d	4
2705453	4 ML tocilizumab-anoh 20 MG/ML Injection [Avtozma]	SBD	581c288f-8015-40ef-a4c3-683c96db193d	4
2705435	0.9 ML tocilizumab-anoh 180 MG/ML Auto-Injector	SCD	581c288f-8015-40ef-a4c3-683c96db193d	4
2705425	0.9 ML tocilizumab-anoh 180 MG/ML Prefilled Syringe	SCD	581c288f-8015-40ef-a4c3-683c96db193d	4
2705443	10 ML tocilizumab-anoh 20 MG/ML Injection	SCD	581c288f-8015-40ef-a4c3-683c96db193d	4
2705450	20 ML tocilizumab-anoh 20 MG/ML Injection	SCD	581c288f-8015-40ef-a4c3-683c96db193d	4
2705452	4 ML tocilizumab-anoh 20 MG/ML Injection	SCD	581c288f-8015-40ef-a4c3-683c96db193d	4
2705439	Avtozma 162 MG per 0.9 ML Auto-Injector	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705432	Avtozma 162 MG per 0.9 ML Prefilled Syringe	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705439	Avtozma 180 MG/ML per 0.9 ML Auto-Injector	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705432	Avtozma 180 MG/ML per 0.9 ML Prefilled Syringe	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705448	Avtozma 20 MG/ML per 10 ML Injection	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705451	Avtozma 20 MG/ML per 20 ML Injection	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705453	Avtozma 20 MG/ML per 4 ML Injection	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705448	Avtozma 200 MG per 10 ML Injection	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705451	Avtozma 400 MG per 20 ML Injection	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705453	Avtozma 80 MG per 4 ML Injection	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705435	tocilizumab-anoh 162 MG per 0.9 ML Auto-Injector	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705425	tocilizumab-anoh 162 MG per 0.9 ML Prefilled Syringe	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705435	tocilizumab-anoh 180 MG/ML per 0.9 ML Auto-Injector	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705425	tocilizumab-anoh 180 MG/ML per 0.9 ML Prefilled Syringe	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705443	tocilizumab-anoh 20 MG/ML per 10 ML Injection	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705450	tocilizumab-anoh 20 MG/ML per 20 ML Injection	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705452	tocilizumab-anoh 20 MG/ML per 4 ML Injection	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705443	tocilizumab-anoh 200 MG per 10 ML Injection	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705450	tocilizumab-anoh 400 MG per 20 ML Injection	SY	581c288f-8015-40ef-a4c3-683c96db193d	4
2705452	tocilizumab-anoh 80 MG per 4 ML Injection	SY	581c288f-8015-40ef-a4c3-683c96db193d	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72606-042-01	72606004201	1 VIAL, SINGLE-DOSE in 1 CARTON (72606-042-01) / 4 mL in 1 VIAL, SINGLE-DOSE	2025-01-26	No	No	Current
72606-042-02	72606004202	4 VIAL, SINGLE-DOSE in 1 CARTON (72606-042-02) / 4 mL in 1 VIAL, SINGLE-DOSE	2025-01-26	No	No	Current